The Medical Letter on Drugs and Therapeutics
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In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults
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The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a booster dose for all adults ≥18 years old after primary immunization with either the same COVID-19 vaccine or a different one. Booster doses of these vaccines were previously authorized only for select populations (age ≥65 years or persons at high risk for severe COVID-19). The EUA for the adenovirus-based vaccine manufactured by Johnson & Johnson was amended in October 2021 to include administration of a booster dose for all adults ≥18 years old after immunization with either the Johnson & Johnson vaccine or a different one.1

A single booster dose of either mRNA-based COVID-19 vaccine can now be administered ≥6 months after a primary series of an mRNA-based vaccine or ≥2 months after a single primary dose of the Johnson & Johnson vaccine in all adults ≥18 years old. A single booster dose of the adenovirus-based COVID-19 vaccine can be administered ≥2 months after a single primary dose of the Johnson & Johnson vaccine (or ≥6 months after a primary series of an mRNA-based vaccine) in any adult (see Table 1)2-4

Adverse effects with a third dose of an mRNA-based COVID-19 vaccine appear to be similar to those with the second primary-series dose and adverse effects with a booster dose of the Johnson & Johnson vaccine appear to be similar to those with the primary dose.

The booster dose is the same as the dose for primary immunization for both Comirnaty (30 mcg [0.3 mL] IM) and the Johnson & Johnson vaccine (5x1010 viral particles [0.5 mL] IM); it is half the dose for primary immunization for Spikevax (50 mcg [0.25 mL] vs 100 mcg [0.5 mL] IM).5-7

Additional Content Available:

COVID-19 Vaccine Dosing Recommendations
COVID-19 Vaccine Comparison Chart

  1. Booster doses of COVID-19 vaccines. Med Lett Drugs Ther 2021; 63:186.
  2. FDA News Release. Coronavirus (COVID-19) update: FDA expands eligibility for COVID-19 vaccine boosters. November 19, 2021. Available at: https://bit.ly/3FQS6S7. Accessed November 22, 2021.
  3. FDA News Release. Coronavirus (COVID-19) update: FDA takes additional actions on the use of a booster dose for COVID-19 vaccines. October 20, 2021. Available at: https://bit.ly/3vJJPLy. Accessed November 22, 2021.
  4. CDC News Release. CDC expands eligibility for COVID-19 booster shots to all adults. November 19, 2021. Available at: https://bit.ly/3cFk1aJ. Accessed November 22, 2021.
  5. FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). November 19, 2021. Available at: https://bit.ly/37fX1NG. Accessed November 22, 2021.
  6. FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). November 19, 2021. Available at: https://bit.ly/3e6KEaD. Accessed November 22, 2021.
  7. FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). November 19, 2021. Available at: https://bit.ly/3nosylA. Accessed November 22, 2021.
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